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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87051

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 28, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Akorn, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16

D-0221-2021
Recall number
D-0221-2021
Initiated
December 28, 2020
Classification
Class II
Status
Terminated
Recalling firm
Akorn, Inc.
Quantity
22,248 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective container: Customer complaints for oral solution leaking from bottles.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective container: Customer complaints for oral solution leaking from bottles.

Code information

Lot #: 373859, 373863, and 373865, Exp 05/2022; 374586, Exp 06/2022

Distribution pattern

Nationwide in the USA and Puerto Rico